On February 12, 2019 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the fourth quarter and full year 2018 (Press release, BerGenBio, FEB 12, 2019, View Source [SID1234533282]). A presentation of the results by the Company’s management will take place today at 10.00 am CET in Oslo – details below.

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Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "BerGenBio made important progress in 2018 and met all its key operational milestones. The strength of the clinical data coupled with correlation with AXL biomarker expression has allowed us to confirm our clinical development strategy in AML and NSCLC. In 2019 we will focus on initiating late stage clinical trials in these indications and we look forward to providing further details and updates during the coming year."

Highlights – Fourth Quarter 2018
Superior monotherapy efficacy of bemcentinib in relapsed/refractory (R/R) AML/MDS patients reported at ASH (Free ASH Whitepaper) 2018 – a possible first registration path

43% ORR with bemcentinib monotherapy in AXL-biomarker-positive R/R AML/MDS patients
Enrolment complete into the phase II combination cohort of the study testing bemcentinib and decitabine in first-line AML, top-line results anticipated in 1Q 2019
Superior progression-free-survival (PFS) and response rate (ORR) in AXL positive advanced NSCLC patients receiving bemcentinib/KEYTRUDA combination presented as late breaking abstract at SITC (Free SITC Whitepaper) 2018

5.9 months median PFS in AXL-positive vs. 3.3 months in AXL-negative patients
40% ORR & 70% clinical benefit rate in AXL-positive patients, including PD-L1 negative patients for whom KEYTRUDA monotherapy is not expected to work
Stage 2 of the two-part trial open and enrolling
Novel tissue- and blood-based biomarkers of AXL expression identified and qualified across multiple clinical trials with bemcentinib: potential for development as companion diagnostics

Selected as a poster discussion at ESMO (Free ESMO Whitepaper) and presented as poster at SITC (Free SITC Whitepaper) 2018
Clinical development team strengthened

Team strengthened and expanded, particularly in key medical, clinical operations and regulatory functions in preparation for advancing bemcentinib into the next stages of clinical development
Financial Highlights
(Figures in brackets = same period 2017 unless otherwise stated)

Total operating expenses for the fourth quarter were NOK 53.2 million (NOK 47.5 million). Total operating expenses for the full year 2018 amounted to NOK 196.9 million (NOK 183.7 million)
Research and development expenses accounted for 78.1 % of total operating expenses in Q4, and 73.7 % for the full year 2018
Comprehensive loss for the fourth quarter amounted to NOK 51.1 million (loss of NOK 47.6 million). Comprehensive loss for the full year 2018 was NOK 191.7 million (loss of NOK 182.2 million)
Cash and cash equivalents amounted to NOK 360.4 million at the end of December 2018 (NOK 398.2 million at 30 September 2018 and NOK 370.3 million at 31 December 2017)
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place at 10.00 am CET at: Hotel Continental, Stortingsgaten 24/26, 0117 Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/ Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and the presentation will be available at www.bergenbio.com in the section: Investors/ Financial Reports from 7:00 am CET the same day.

END

About AXL
AXL kinase is cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.

On February 12, 2019 Anchiano Therapeutics Ltd. (Nasdaq and TASE: ANCN) ("Anchiano") reported that it has priced its initial public offering of 2,652,174 of its American Depositary Shares ("ADSs"), each representing five ordinary shares of Anchiano, at $11.50 per ADS, less underwriting discounts and commissions (Press release, Anchiano Therapeutics, FEB 12, 2019, View Source [SID1234533277]). The ADSs are expected to begin trading on the Nasdaq Capital Market ("Nasdaq") under the symbol "ANCN" on February 12, 2019, and the offering is expected to close on or about February 14, 2019.

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The underwriters have been granted a 30-day option to purchase up to an additional 397,826 ADSs offered by Anchiano to cover over-allotments, if any.

In the offering, Oppenheimer & Co. Inc. is acting as the sole book-running manager, Ladenburg Thalmann is acting as lead manager and LifeSci Capital LLC is acting as co-manager.

The offering is being made only by means of a prospectus, copies of which can be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at [email protected].

A registration statement relating to these securities was filed with and declared effective by the U.S. Securities and Exchange Commission on February 11, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to their registration or qualification under the securities laws of any such state or jurisdiction

On February 12, 2019 Anchiano Therapeutics Ltd. (Nasdaq and TASE: ANCN) ("Anchiano") reported that it has priced its initial public offering of 2,652,174 of its American Depositary Shares ("ADSs"), each representing five ordinary shares of Anchiano, at $11.50 per ADS, less underwriting discounts and commissions (Press release, Anchiano Therapeutics, FEB 12, 2019, View Source [SID1234533276]). The ADSs are expected to begin trading on the Nasdaq Capital Market ("Nasdaq") under the symbol "ANCN" on February 12, 2019, and the offering is expected to close on or about February 14, 2019.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The underwriters have been granted a 30-day option to purchase up to an additional 397,826 ADSs offered by Anchiano to cover over-allotments, if any.

In the offering, Oppenheimer & Co. Inc. is acting as the sole book-running manager, Ladenburg Thalmann is acting as lead manager and LifeSci Capital LLC is acting as co-manager.

The offering is being made only by means of a prospectus, copies of which can be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at [email protected].

A registration statement relating to these securities was filed with and declared effective by the U.S. Securities and Exchange Commission on February 11, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to their registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2019 OncoCyte Corporation (NYSE American: OCX) ("OncoCyte"), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported the closing of an underwritten public offering (Press release, Oncocyte, FEB 12, 2019, View Source [SID1234533275]). Following the exercise in full by the underwriters of their option to purchase up to an additional 1,400,000 shares of common stock at the public offering price, OncoCyte sold 10,733,334 shares of its common stock at a public offering price of $3.75 per share, for aggregate gross proceeds of approximately $40.25 million, from the Company’s existing shelf registration statement .

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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OncoCyte intends to use the net proceeds of the public offering to support its DetermaVuTM commercialization efforts and additional clinical studies to support reimbursement and adoption, to initiate future product development, and for general corporate and working capital purposes.

Piper Jaffray is acting as the sole book-running manager and Janney Montgomery Scott is acting as the co-manager for the offering.

The shares are being offered by OncoCyte pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on October 2, 2017 and declared effective by the SEC on October 16, 2017. The offering is being made only by means of a written prospectus and prospectus supplement. A final prospectus supplement (and accompanying base prospectus) relating to the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Alternatively, copies of the final prospectus supplement (and accompanying base prospectus) relating to the offering may be obtained from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by phone at (800) 747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the availability of preliminary results from the Phase II CALYPSO study of the savolitinib / Imfinzi (durvalumab) combination in a cohort of patients with metastatic papillary renal cell carcinoma ("PRCC"), an investigator initiated study led by Professor Thomas Powles, Lead for Solid Tumour Research at Barts Cancer Institute, and sponsored by Queen Mary University of London (Press release, Hutchison China MediTech, FEB 12, 2019, View Source [SID1234533272]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Full data from the PRCC cohort of the CALYPSO study will be presented on Saturday, February 16, 2019, in oral and poster presentations at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU") in San Francisco, CA.

Further details from the presentation are as follows:

Presentation Title:

A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO)

First Author:

Thomas Powles, MD, PhD, FCRP

Abstract No:

545

Oral Presentation:

Oral Abstract Session C: Renal Cell Cancer

Date & Time:

Saturday, February 16: 2:00 PM-3:30 PM PST

Poster Presentation:

Session C: Renal Cell Cancer

Date & Time:

Saturday, February 16: 7:00 AM-7:55 AM and 12:30 PM-2:00 PM PST

About PRCC in the CALYPSO study

PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for this specific indication. The CALYPSO study is an independently sponsored open-label Phase II study of Imfinzi in combination with several drug candidates in the treatment of renal cell carcinoma in the U.K. and Spain. Several arms of CALYPSO are evaluating the treatment of PRCC and clear cell renal carcinoma (ccRCC) with savolitinib, a highly selective inhibitor of the c-MET receptor tyrosine kinase, both as a monotherapy and in combination with Imfinzi (durvalumab), AstraZeneca’s anti-programmed death-ligand 1 ("PD-L1") antibody. CALYPSO enrolls an all-comer PRCC population with planned retrospective molecular profiling. For further details, please refer to clinicaltrials.gov number NCT02819596.

About Savolitinib

Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 700 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in PRCC, NSCLC, colorectal cancer (CRC) and gastric cancer with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.